510(k) K853036 ยท GKL Counter, Cell, Automated (Particle Counter)
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
| Applicant | Diagnostic Technology, Inc., Hauppauge NY, US |
| Decision | Substantially Equivalent, Nov 5, 1985 |
| Received | Jul 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853036
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.